Who is the manufacturer of Medline ReNewal Reprocessed Stryker SERF AS Energy Probes?

Surgical Instrument Service and Savings, Inc. filed the 510(k) submission for Medline ReNewal Reprocessed Stryker SERF AS Energy Probes (K172608).

What is the FDA product code for Medline ReNewal Reprocessed Stryker SERF AS Energy Probes?

NUJ. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Medline ReNewal Reprocessed Stryker SERF AS Energy Probes?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Medline ReNewal Reprocessed Stryker SERF AS Energy Probes?

Stryker SERFAS Energy Probes (K041810).

Who can help prepare an FDA 510(k) submission like Medline ReNewal Reprocessed Stryker SERF AS Energy Probes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medline ReNewal Reprocessed Stryker SERF AS Energy Probes

K172608 · Surgical Instrument Service and Savings, Inc. · NUJ · Oct 18, 2017 · General, Plastic Surgery

Device Facts

Record ID	K172608
Device Name	Medline ReNewal Reprocessed Stryker SERF AS Energy Probes
Applicant	Surgical Instrument Service and Savings, Inc.
Product Code	NUJ · General, Plastic Surgery
Decision Date	Oct 18, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist.

Device Story

Disposable radio frequency (RF) probe for electrosurgical procedures; used in arthroscopic surgery (knee, shoulder, ankle, hip, elbow, wrist). Device inputs: RF energy from compatible generator; manual control via integrated finger switches or foot switches. Device transforms electrical energy to perform soft tissue resection, ablation, coagulation, and hemostasis; includes suction line for removal of tissue/fluids. Operated by surgeons in clinical/OR settings. Output: thermal energy for tissue effect; suction for site clearance. Benefits: enables minimally invasive arthroscopic tissue management. Reprocessed device undergoes cleaning, disinfection, inspection, refurbishment, testing, and sterilization.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via sterilization validation, biocompatibility (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity), electrical safety (IEC 60601-1, IEC 60601-2-2), electromagnetic compatibility (IEC 60601-1-2), and performance qualification (simulated use, bending, suction, thermal tissue damage, drop, integrity, stability, and cleaning/protein/hemoglobin residue testing).

Technological Characteristics

Radio frequency electrosurgical probe; disposable. Features integrated finger switches and suction line. Compatible with Stryker SERFAS and Crossfire energy systems. Standards: IEC 60601-1 (general safety), IEC 60601-2-2 (electrosurgical safety), IEC 60601-1-2 (EMC). Sterilization: validated process for reprocessed single-use devices.

Indications for Use

Indicated for patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist requiring soft tissue resection, ablation, coagulation, or hemostasis.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Stryker SERFAS Energy Probes (K041810)

Related Devices

K121855 — RESPROCESSED SERFAS ENERGY PROBE · Stryker Sustainability Solutions · Aug 16, 2012
K171391 — Stryker 90-S Max SERFAS Energy Probe · Stryker · Jan 26, 2018
K012631 — REPROCESSED SOFT TISSUE ABLATORS · Alliance Medical Corp. · Dec 6, 2001
K173740 — Reprocessed DePuy Mitek Ablation Wand · Renovo, Inc. · Mar 19, 2018
K012679 — REPROCESSED RF ARTHROSCOPY PROBES · Sterilmed, Inc. · Nov 8, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration". October 18, 2017 Surgical Instrument Service and Savings (dba Medline ReNewal) Ms. Stephanie Boyle Mays Regulatory Specialist, Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave. Redmond, Oregon 97756 Re: K172608 Trade/Device Name: Medline ReNewal Reprocessed Stryker SERF AS Energy Probes (Models:279-351-100, 279-351-230, 279-351-250, 279-351-300,279-351-400, and 279-401-100) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: August 30, 2017 Received: August 31, 2017 Dear Ms. Mays: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good {1}------------------------------------------------ manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. # Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172608 #### Device Name Medline ReNewal Reprocessed Stryker SERFAS Energy Probes (models: 279-351-230, 279-351-250, 279-351-300, 279-351-400, and 279-401-100) #### Indications for Use (Describe) The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist. Type of Use (Select one or both, as applicable) | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------| | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Device Model | Device Name | Original Manufacturer | |-----------------|--------------------------------------------------------|--------------------------| | 279-351-100 | 90-S SERFAS Energy Suction Probe 3.5 mm | Stryker | | 279-351-230 | 30-S SERFAS Energy Suction Probe 3.5 mm | Stryker | | 279-351-250 | 50-S SERFAS Energy Suction Probe 3.5 mm | Stryker | | 279-351-300 | Super 90-S SERFAS Energy Suction Probe 3.5 mm | Stryker | | 279-351-400 | 90-S Accelerator SERFAS Energy Suction Probe 3.5 mm | Stryker | | 279-401-100 | 90-S MAX SERFAS Energy Suction Probe 4.0 mm | Stryker | Reprocessed Single-Use Device Models Included in Clearance: {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue symbol to the left of it. To the right of "Medline" is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in blue. # 510(k) Summary This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92. | Submitter/ Owner | Surgical Instrument Service and Savings (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared | August 30, 2017 | | Contact Name/Prepared by | Stephanie Boyle Mays Regulatory Affairs Specialist, Regulatory Affairs P: 541-516-4205/F: 541-923-3375 E: smays@medline.com | | Device Name and Classification | Propriety/Trade Name: Medline ReNewal Reprocessed Stryker SERFAS Energy Probes, models: 279-351-100, 279-351-230, 279-351-250, 279-351-300, 279- 351-400, and 279-401-100 Common Name: Electrosurgical cutting and coagulation device and accessories Classification: Class II Regulation Number: 21 CFR § 878.4400 Product Code: NUJ Panel: General & Plastic Surgery | | 510(k) Number | K041810 | | | Propriety/Trade Name: Stryker SERFAS Energy Probes, models: 279- 351-100, 279-351-230, 279-351-250, 279-351- 300, 279-351-400, and 279-401-100 | | Predicate Device and Classification | Common Name: Electrosurgical cutting and coagulation device and accessories Classification: Class II Regulation Number: 21 CFR § 878.4400 Product Code: GEI Panel: General & Plastic Surgery Manufacturer: Stryker Endoscopy, 5900 Optical Ct., San Jose, CA 95138 | | Intended Use | The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist. | | Product Description | The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes are single-use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. All models can be operated with integrated finger switches on the device handle to control ablation, coagulation and power level. Each model also has a suction line that removes tissue and fluids from the surgical site. In addition, the models can be operated with foot switches, which offer another mode with which to | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left, with the word "MEDLINE" in blue and a blue star symbol. To the right of the Medline logo is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in blue below it. | Device Characteristics | Predicate | Proposed | Comparison | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | 510(k) | Stryker SERFAS Energy Probes | Medline ReNewal Reprocessed Stryker SERFAS Energy Probes | As Stated | | 510(k) | K041810 | TBD | Not applicable | | Model Numbers | • 279-351-100 • 279-351-230 • 279-351-250 • 279-351-300 • 279-351-400 • 279-401-100 | • 279-351-100 • 279-351-230 • 279-351-250 • 279-351-300 • 279-351-400 • 279-401-100 | Same | | Intended Use | The SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist. The probe includes an energy-transferring cable as well as several different tip configurations and suction probes which are capable of providing simultaneous fluid aspirations | The Medline ReNewal Reprocessed SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist. The probe includes an energy-transferring cable as well as several different tip configurations and suction probes which are capable of providing simultaneous fluid aspirations. | Same | | 510(k) Substantial Equivalence Chart (concluded) | | | | | | Predicate | Proposed | Comparison | | Device Characteristics | Stryker SERFAS Energy Probes | Medline ReNewal Reprocessed Stryker SERFAS Energy Probes | As Stated | | Product Description | The Stryker SERFAS Energy Probes are single- use devices. All models can be operated with integrated finger switches on the device handle to control ablation, coagulation and power level. Each model also has a suction line that removes tissue and fluids from the surgical site. In addition, the models can be operated with foot switches, which offer another mode with which to control ablation, coagulation, and the power setting. The devices are connected to the appropriate generator by a connector cable. | The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes are single-use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. All models can be operated with integrated finger switches on the device handle to control ablation, coagulation and power level. Each model also has a suction line that removes tissue and fluids from the surgical site. In addition, the models can be operated with foot switches, which offer another mode with which to control ablation, coagulation, and the power setting. The devices are connected to the appropriate generator by a connector cable. The generators and the foot switches are not included in the scope of this project, and they will not be reprocessed. | As stated | | Power Platform | Stryker SERFAS ● Energy System Stryker Crossfire ● System | Stryker SERFAS ● Energy System Stryker Crossfire ● System | Same | | Technological Characteristics | The technological characteristics and the fundamental scientific technology of the subject devices are identical to the predicate device. The proposed devices are a reprocessed version of the predicate K041810 Stryker SERFAS Energy Probes. The predicate devices were used to support intended use, technological characteristics, and functional performance specifications. | | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are in smaller blue letters below the Renewal logo. The logo is clean and professional. | Performance Testing | The functional characteristics of the proposed Medline ReNewal Reprocessed Stryker SERFAS Energy Probe have been evaluated and found to be equivalent to the Stryker SERFAS Energy Probe predicate devices based on the following tests: | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | sterilization validation; | | | biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; | | | electrical testing electromagnetic compatibility (in accordance with IEC 60601-1-2); electrical safety (in accordance with IEC 60601-1 and IEC 60601-2-2); and basic safety (in accordance with IEC 60601-1 and IEC 60601-2-2) | | | performance qualification: simulated use; critical function bending equivalence test; critical function suction equivalence test; critical function thermal tissue damage equivalence test; critical function drop equivalence test; critical function device equivalence integrity; and product stability | | | cleaning; protein, and hemoglobin. | | | Conclusion |